Trials / Recruiting
RecruitingNCT06568471
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Hasten Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \[≤31 days\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study. Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland China. All eligible participants will be randomized in a 2:1 ratio to HST101 or placebo dosed subcutaneously (Q4W \[≤31 days\]) in the initial 12-week randomized double-blind treatment period. After 12-week treatment, all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period, and those who are on placebo will be switched to HST101 300 mg (Q4W \[≤31 days\]) administered subcutaneously. The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period, 12-week randomized, double-blind, placebo-controlled treatment period, 36-week open-label treatment period, followed by a 4-week follow-up period.
Conditions
- Hypercholesterolemia
- Dyslipidemias
- Primary Hypercholesterolemia
- Heterozygous Familial Hypercholesterolemia
- Hyperlipidemia; Mixed
- Metabolic Disease
- ASCVD
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lerodalcibep | PCSK9 inhibitor |
| DRUG | matching placebo | placebo |
Timeline
- Start date
- 2024-11-16
- Primary completion
- 2026-02-01
- Completion
- 2026-05-01
- First posted
- 2024-08-23
- Last updated
- 2025-02-06
Locations
18 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06568471. Inclusion in this directory is not an endorsement.